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A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00234520
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : June 27, 2008
Sponsor:
Information provided by:
Ipsen

Brief Summary:
The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide

Condition or disease Phase
Acromegaly Phase 4

Study Type : Observational
Estimated Enrollment : 200 participants
Time Perspective: Prospective
Official Title: A Multicentre Prospective Controlled Observer Blinded Cohort Study in Patients With Acromegaly to Evaluate the Risk of Cardiac Valvular Regurgitation in Patients Treated With Lanreotide Relative to Patients Treated With Octreotide
Study Start Date : May 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months

Secondary Outcome Measures :
  1. Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months
  2. Risk in each of the 4 valves at 6 & 12 months
  3. Risk of significant regurgitation in each valve at 6 & 12 months
  4. Prevalence of valvular regurgitation at baseline
  5. Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a diagnosis of Acromegaly
  • Patient is being treated with lanreotide or octreotide in any dose form at the selection visit or is a de novo patient who is due to commence treatment within 2 weeks of baseline
  • Patient started treatment with either lanreotide or octreotide when both products were available on the market in their country
  • Patient must not change treatment form lanreotide to octreotide or vice versa for the duration of the study

Exclusion Criteria:

  • Patients with known significant valve abnormalities prior to treatment with either lanreotide or octreotide
  • Patients who have received treatment with a somatostatin analogue other than lanreotide or octreotide for more than 3 months
  • Patients who have received treatment with a GH antagonist for more than 3 months
  • Patients who have had heart valve replacement therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234520


  Show 33 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: France Catus, MD Ipsen

Publications:
ClinicalTrials.gov Identifier: NCT00234520     History of Changes
Other Study ID Numbers: 2-47-52030-721
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: June 27, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Lanreotide
Angiopeptin
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents